Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites "the free edges have a "V" shape". Examiner takes the stance a chevron pattern, recited in claim 1, is defined as a shape like a V and also as defined in paragraph [0053] of the present application. Claim 2 does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moe (US 2001/0049556 A1) in view of Yohanan (US 2013/0150956 A1).
Regarding claim 1, Moe teaches a valve prosthesis (10, heart valve, fig. 1) comprising: a one-piece molded valve (¶ [0021]) comprising: valve leaflets (18, leaflets, fig. 1) having free edges (22, free margin, fig. 1).
Moe fails to teach free edges in a chevron down pattern. However, Yohanan teaches a heart valve with leaflets that include free edges in a chevron down pattern (336, upper edge, fig. 19). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the free edges of Moe to include a chevron down pattern as taught by Yohanan in order to allow the prosthetic valve to be crimped to a smaller diameter for delivery (¶ [0081], Yohanan).
Regarding claim 2, Moe fails to teach the free edges have a “V” shape. However, Yohanan further teaches the free edges have a "V" shape (fig. 19). As explained above, examiner notes chevron is defined as “a shape like a V”, this is not further limiting the claim 1. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the free edges of Moe to include a "V" shape as taught by Yohanan in order to allow the prosthetic valve to be crimped to a smaller diameter for delivery (¶ [0081], Yohanan).
Regarding claim 3, Moe further teaches the one-piece molded valve further comprises commissures, tops of the "V" shape of each free edge meeting at the commissures (see annotated fig. 2, below).
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Regarding claim 4, Moe further teaches the one-piece molded valve further comprises commissures (see annotated fig. 2, below), the free edges slanting proximally from the commissures (see annotated fig. 2, below).
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Regarding claim 5, Moe further teaches the one-piece molded valve further comprises commissures, the free edges meeting in an area of coaptation that is proximal of the commissures (see annotated fig. 1, below).
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Claim(s) 6-7 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moe (US 2001/0049556 A1) in view of Levi (US 2015/0320556 A1).
Regarding claim 6, Moe teaches a valve prosthesis comprising: a one-piece molded valve (¶ [0021]) comprising: valve leaflets (18, leaflets, fig. 1) defined by cusps (20, attachment curve, fig. 1).
Moe fails to teach an attachment that band follow the contour of the cusps. However, Levi teaches a heart valve with leaflets that includes an attachment band abutting and proximal of the cusps (72, reinforcing strip, fig. 22) , the attachment band following a contour of the cusps (fig. 22). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe to include an attachment band that follows the contour of the cusps as taught by Levi in order to protect the pericardial tissue of the leaflets structure of tears (¶ [0055], Levi).
Regarding claim 7, Moe fails to teach a parabolic shaped inflow end defined by the attachment band. However, Levi further teaches the one-piece molded valve further comprises a parabolic shaped inflow end defined by the attachment band (108, lower edge portion, fig. 21). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe to include a parabolic shaped inflow end defined by the attachment band as taught by Levi in order to protect the pericardial tissue of the leaflets structure of tears (¶ [0055], Levi).
Regarding claim 13, Moe fails to teach a stent structure and stitching attached the attachment band to the stent structure. However, Levi further teaches a stent structure (12, frame, fig. 1); and stitching attaching the attachment band to the stent structure (¶ [0055]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe to include a stent structure and stitching attached the attachment band to the stent structure as taught by Levi in order to protect the pericardial tissue of the leaflets structure of tears (¶ [0055], Levi).
Regarding claim 14, Moe fails to teach an outer skirt. However, Levi further teaches the stent structure comprises an inflow portion (15, inflow end, fig. 15), the valve prosthesis further comprising: an outer skirt covering an outer surface of the inflow portion (18, outer skirt, fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe to include an outer skirt as taught by Levi in order to protect the pericardial tissue of the leaflets structure of tears (¶ [0055], Levi).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moe in view of Levi as applied to claim 6 above, and further in view of Coe (US 2019/0269507 A1).
Regarding claim 8, Moe and Levi fail to teach the attachment band is integral with the valve leaflets. However, Coe teaches a heart valve that includes the attachment band is integral with the valve leaflets (see annotated fig. 1(c), below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe and Levi to include the attachment band is integral with the valve leaflets as taught by Coe since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the attachment band integral with the valve leaflets, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art (see MPEP 2144.04.V).
Regarding claim 9, Moe and Levi fail to teach a first layer integral with the leaflets and a reinforcement layer attached to the first layer. However, Coe further teaches the attachment band comprises a first layer that is integral with the valve leaflets (see annotated fig. 1(c), below) and a second reinforcement layer attached to the first layer (see annotated fig. 1(c), below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe and Levi to include a first layer integral with the leaflets and a reinforcement layer attached to the first layer as taught by Coe since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 10, Moe further teaches an inflow end of the on-piece molded valve (16, fig. 2).
Moe and Levi fail to teach the attachment band comprises a first layer, a second reinforcement layer integral with the leaflets. However, Coe further teaches the attachment band comprises a first layer (see annotated fig. 1(c), below) and a second reinforcement layer (see annotated fig. 1(c), below) that are integral with the valve leaflets, the second reinforcement layer being folded from the first layer (see annotated fig. 1(c), below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe and Levi to include the attachment band comprises a first layer, a second reinforcement layer integral with the leaflets as taught by Coe since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 11, Moe and Levi fail to teach stitching attaching the first and second layers. However, Coe further teaches stitching attaching the second reinforcement layer to the first layer (238, sutures, fig. 1(c)). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe and Levi to include stitching attaching the first and second layers as taught by Coe since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moe in view of Levi and Coe as applied to claim 10 above, and further in view of Adamek-Bowers (US 2019/0262507 A1).
Regarding claim 12, Moe and Levi fail to teach the first and second layers define a pocket. However, Coe further teaches the first layer and the second reinforcement layer define a pocket (see annotated fig. 1(c), below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe and Levi to include the first and second layers define a pocket as taught by Coe since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Moe, Levi and Coe fail to teach a radiopaque material. However, Adamek-Bowers teaches a heart valve that includes a radiopaque material (34, radiopaque element, ¶ [0012]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the valve of Moe, Levi and Coe to include a radiopaque material as taught by Adamek-Bowers in order to locate and/or position the replacement heart valve (¶ [0077], Adamek-Bowers).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moe in view of Levi as applied to claim 14 above, and further in view of Hoang (WO 2018/222799 A1).
Regarding claim 15, Moe and Levi fail to teach and inner liner and a fuzzy outer layer. However, Hoang teaches a prosthetic valve that includes the outer skirt comprises: an inner liner (170, base layer, fig. 23); and a fuzzy outer layer (172, pile layer, fig. 23).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the outer skirt of Moe and Levi to include an inner liner and a fuzzy outer layer as taught by Hoang in order to cushion and seal against native tissue surrounding the prosthetic valve (¶ [0100], Hoang).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 2012/0089223 A1).
Regarding claim 16, Nguyen teaches a valve prosthesis comprising: a stent structure (412, frame, fig. 33) comprising an inflow portion (see annotated fig. 33, below);
a prosthetic valve coupled to the stent structure, the prosthetic valve comprising: valve leaflets (460, leaflets, fig. 33) defined by cusps (464, curved lower edges, fig. 30) ; and a valve inflow cylinder (416, flat sheet, lower part, see annotated fig. 30) proximal of the cusps; and
an inner skirt (416, flat sheet, upper part, see annotated fig. 30, below) attached to an inner surface of the inflow portion (¶ [0097], fig. 33), the inner skirt extending distally from the cusps to an outflow crown ring of the inflow portion (fig. 33 and see annotated fig. 30, below), the valve inflow cylinder being directly attached to the inflow portion proximal of the inner skirt (fig. 33).
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Regarding claim 17, Nguyen further teaches the inner skirt is provided between the valve leaflets and the inflow portion (fig. 32).
Regarding claim 18, Nguyen further teaches the inner skirt does not overlap the valve inflow cylinder (fig. 30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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